title: Sodium oxybate reduces pain, fatigue, and sleep disturbance and improves functionality in fibromyalgia: results from a 14-week, randomized, double-blind, placebo-controlled study.
abstract: This 14-week, phase 3, double-blind, randomized, controlled trial evaluated sodium oxybate (SXB) 4.5 and 6g per night versus placebo in patients with fibromyalgia (FM). SXB is the sodium salt of γ-hydroxybutyrate (GHB). GHB is an endogenous compound, synthesized from γ-aminobutyric acid (GABA) and found broadly in the central nervous system and body. Among 548 randomized patients, a ≥30% reduction in pain was experienced by 54.2% and 58.5% of patients treated with SXB 4.5 and 6g, respectively, versus 35.2% for placebo with a 100-mm Visual Analog Scale (VAS) (P<0.001 for both comparisons). Relative to placebo, both SXB doses significantly reduced fatigue (with a 100-mm VAS; P<0.001) and sleep disturbance (with the Jenkins Sleep Scale; P<0.001), and resulted in significant improvements in function as measured by the FM Impact Questionnaire (P=0.003 and P=0.001 for 4.5 and 6 g per night, respectively). On the Short-Form 36 Health Survey, SXB-related improvement was significant on the Physical, but not the Mental, Component Scale. The proportion of patients who reported a global improvement of "much" or "very much" better on the Patient Global Impression of Change was significantly greater in both SXB groups versus placebo (P<0.001). Headache, nausea, dizziness, vomiting, diarrhea, anxiety, and sinusitis were the most commonly reported adverse events, with an incidence at least twice that of placebo. These results expand the evidence from previous clinical trials suggesting that SXB is effective and safe in FM.
authors.affiliation: Department of Medicine, University of Texas Health Science Center at San Antonio, TX, USA Pacific Rheumatology Associates, Inc, Renton, WA, USA Houston Sleep Center, University of Texas-Houston School of Medicine, Houston, TX, USA Jazz Pharmaceuticals, Inc, Palo Alto, CA, USA.
authors.forename: Jon I
authors.initials: JI
authors.lastname: Russell
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Holman
authors.forename: Todd J
authors.initials: TJ
authors.lastname: Swick
authors.forename: Sarah
authors.initials: S
authors.lastname: Alvarez-Horine
authors.forename: Grace Y
authors.initials: GY
authors.lastname: Wang
authors.forename: Diane
authors.initials: D
authors.lastname: Guinta
mesh_terms: D000759:Adjuvants, Anesthesia / Q000627:therapeutic use*; D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005356:Fibromyalgia / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D011788:Quality of Life; D012893:Sleep Wake Disorders / Q000188:drug therapy / Q000209:etiology; D012978:Sodium Oxybate / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000759:Adjuvants, Anesthesia; D012978:Sodium Oxybate